Removable Walker for Neuropathic Ulcers

Last updated: October 29, 2009
Sponsor: IRCCS Multimedica
Overall Status: Completed

Phase

3

Condition

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT01005264
05/2007cardiovascolare
  • Ages 18-80
  • All Genders

Study Summary

  1. Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer

  2. Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The presence of neuropathic plantar ulcer with an area graded IA according to theTexas University classification, AND

  • The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based oninsensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas ofthe foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus > 25 volts.

Exclusion

Exclusion Criteria:

  • Presence of an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygentension (TcPO2) < 50 mmHg tested on the dorsum of the foot,

  • Presence of clinical signs of infection, including edema, erythema, increased localskin temperature, or drainage,

  • The probe-to-bone maneuver was required to be negative,

  • Tthe standard X-ray examination of the foot was required to be negative forosteomyelitis,

  • Use of steroids or cytostatic drugs,

  • Presence of sensory, motor, or visual problems that could impair functional autonomy,

  • Active ulcer on the contralateral foot,

  • Previous major amputation of the contralateral limb,

  • Previous or current deep venous leg thrombosis, OR

  • Mental disorders interfering with patient compliance.

Study Design

Total Participants: 48
Study Start date:
February 01, 2008
Estimated Completion Date:
March 31, 2009

Study Description

Study design:

Two centers specializing in diabetic foot management (located in Sesto S. Giovanni and Milan, Italy) participated to this open, randomized clinical trial. The ethics-committee approved the study on January 10th, 2008. Enrollment of consecutive patients began February 2008 and ended March 2009. Eligible patients were fully informed of the study aim and procedures and written consent was obtained prior to study participation. Patients were then randomly assigned to one of the two treatment groups by opening randomization codebreak envelopes containing one of the two options. Separate randomization was performed for each center, and a copy of all randomization envelopes was kept at the statistical department of the Multimedica center. The two arms were composed of patients managed with non-removable fiberglass off-bearing cast (TCC group) and patients offloaded with the Stabil-D® (Podartis srl, Montebelluna, Treviso, Italy) walker cast (Stabil-D group).

Connect with a study center

  • Diabetic Foot Center - IRCCS Multimedica

    Sesto San Giovanni, Milan 20099
    Italy

    Site Not Available

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